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NCT01386658 · ClinicalTrials.gov registry record · Phase 3
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT01386658 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 32 participants.
The verdict
NCT01386658, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study Summary
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.
Interventions
- DRUG icatibant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-01-27 |
| Est. Completion | 2018-03-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01386658
The ClinicalTrials.gov registry entry for NCT01386658 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which icatibant is the first listed.
NCT01386658 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01386658 about?
NCT01386658 is a clinical study titled "A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema". HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) d...
What is the current status of trial NCT01386658?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2012-01-27. Estimated completion is 2018-03-12.
What interventions are being tested in trial NCT01386658?
The interventions under investigation include: icatibant (DRUG).
Who is sponsoring clinical trial NCT01386658?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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